—#103452

Product

Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1. Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K023063
Affected lot / code info: Part numbers: 406993, Lot numbers:176070 and 657550; and 406993-00, Lot number : 203119.

Why it was recalled

Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 8/3/11 Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to locate the affected products, discontinue use, return the devices, and a fax a copy of the response form. For information or questions on this recall call Biomet at (574) 372-1570.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: International Distribution Only: Canada, Australia, and Columbia.

Timeline

Recall initiated: 2011-08-03
Posted by FDA: 2011-09-30
Terminated: 2011-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103452. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.